Trial Outcomes & Findings for MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population (NCT NCT02554279)
NCT ID: NCT02554279
Last Updated: 2023-09-21
Results Overview
Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
620 participants
Primary outcome timeframe
8-9 weeks after blastocyst transfer in the fresh cycle
Results posted on
2023-09-21
Participant Flow
The study was conducted at 31 infertility centers in the US between 31 Aug 2014 to 02 Feb 2017.
Participant milestones
| Measure |
Menotropin
Menotropins for injection, provided as a vial with powder (75 international units \[IU\] follicle stimulating hormone \[FSH\] activity and 75 IU luteinizing hormone \[LH\] activity) and a vial with diluent.
|
Recombinant FSH
Follitropin alpha for injection, a human FSH preparation of recombinant deoxyribonucleic acid (DNA) origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
309
|
|
Overall Study
Treated
|
310
|
309
|
|
Overall Study
Completed Day 6 of Stimulation
|
308
|
309
|
|
Overall Study
Received Trigger
|
293
|
307
|
|
Overall Study
Completed Oocyte Retrieval
|
292
|
306
|
|
Overall Study
Completed Fresh Blastocyst Transfer
|
201
|
191
|
|
Overall Study
COMPLETED
|
279
|
291
|
|
Overall Study
NOT COMPLETED
|
32
|
18
|
Reasons for withdrawal
| Measure |
Menotropin
Menotropins for injection, provided as a vial with powder (75 international units \[IU\] follicle stimulating hormone \[FSH\] activity and 75 IU luteinizing hormone \[LH\] activity) and a vial with diluent.
|
Recombinant FSH
Follitropin alpha for injection, a human FSH preparation of recombinant deoxyribonucleic acid (DNA) origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Other reason
|
19
|
6
|
Baseline Characteristics
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Baseline characteristics by cohort
| Measure |
Menotropin
n=310 Participants
Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Total
n=619 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 3.08 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 3.02 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 3.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
310 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
270 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
310 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8-9 weeks after blastocyst transfer in the fresh cyclePopulation: The modified intent-to-treat (mITT) analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.
Outcome measures
| Measure |
Menotropin
n=310 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Ongoing Pregnancy Rate
|
35.5 percentage of participants
|
30.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positivePopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.
Outcome measures
| Measure |
Menotropin
n=310 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Positive β-human Chorionic Gonadotropin (hCG) Rate
|
40.6 percentage of participants
|
39.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-5 weeks after blastocyst transfer in the fresh cyclePopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation.
Outcome measures
| Measure |
Menotropin
n=310 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Clinical Pregnancy Rate
|
37.1 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 10-11 weeks of gestation in the fresh cyclePopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented.
Outcome measures
| Measure |
Menotropin
n=126 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=122 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Early Pregnancy Loss
|
14.3 percentage of participants
|
23.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)Population: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as average follicle size and average size of 3 largest follicles.
Outcome measures
| Measure |
Menotropin
n=309 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
n=278 Participants
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
n=296 Participants
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Follicular Development as Assessed by TVUS
Average follicle size
|
5.95 mm
Standard Deviation 1.682
|
7.45 mm
Standard Deviation 2.044
|
12.20 mm
Standard Deviation 3.328
|
13.28 mm
Standard Deviation 2.808
|
|
Follicular Development as Assessed by TVUS
Average size of 3 largest follicles
|
9.69 mm
Standard Deviation 3.562
|
12.17 mm
Standard Deviation 2.590
|
21.36 mm
Standard Deviation 2.524
|
21.09 mm
Standard Deviation 2.685
|
SECONDARY outcome
Timeframe: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)Population: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm.
Outcome measures
| Measure |
Menotropin
n=309 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
n=278 Participants
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
n=296 Participants
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Follicular Development as Assessed by TVUS
Follicle size ≤9 mm
|
99.0 percentage of participants
|
96.4 percentage of participants
|
78.4 percentage of participants
|
69.9 percentage of participants
|
|
Follicular Development as Assessed by TVUS
Follicle size 10-11 mm
|
73.8 percentage of participants
|
93.2 percentage of participants
|
82.7 percentage of participants
|
75.7 percentage of participants
|
|
Follicular Development as Assessed by TVUS
Follicle size 12-14 mm
|
50.2 percentage of participants
|
76.1 percentage of participants
|
93.5 percentage of participants
|
96.6 percentage of participants
|
|
Follicular Development as Assessed by TVUS
Follicle size 15-16 mm
|
12.6 percentage of participants
|
24.9 percentage of participants
|
84.9 percentage of participants
|
96.3 percentage of participants
|
|
Follicular Development as Assessed by TVUS
Follicle size ≥17 mm
|
5.2 percentage of participants
|
9.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: At oocyte retrieval visit (approximately 36 hours after hCG administration)Population: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.
Outcome measures
| Measure |
Menotropin
n=292 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=306 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Number of Oocytes Retrieved
|
15.1 oocytes
Standard Deviation 10.12
|
22.2 oocytes
Standard Deviation 11.54
|
—
|
—
|
SECONDARY outcome
Timeframe: At oocyte retrieval visit (approximately 36 hours after hCG administration)Population: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.
Outcome measures
| Measure |
Menotropin
n=292 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=306 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Number of Metaphase II Oocytes
|
10.1 metaphase II oocytes
Standard Deviation 7.18
|
15.9 metaphase II oocytes
Standard Deviation 9.01
|
—
|
—
|
SECONDARY outcome
Timeframe: On day 1 post-inseminationPopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.
Outcome measures
| Measure |
Menotropin
n=289 Participants
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=305 Participants
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Fertilization Rate
|
55.09 percentage of each participant
Standard Deviation 21.731
|
59.07 percentage of each participant
Standard Deviation 18.731
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 days after oocyte retrievalPopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.
Outcome measures
| Measure |
Menotropin
n=2409 Total number of embryos
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=4028 Total number of embryos
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Quality of Embryos
Blastomere uniformity-Equally sized blastomeres
|
63.1 percentage of embryos
|
59.0 percentage of embryos
|
—
|
—
|
|
Quality of Embryos
Cell size classification-Stage specific
|
75.5 percentage of embryos
|
70.8 percentage of embryos
|
—
|
—
|
|
Quality of Embryos
Degree of fragmentation-≤10%
|
81.1 percentage of embryos
|
81.0 percentage of embryos
|
—
|
—
|
|
Quality of Embryos
Multinucleation present
|
0.7 percentage of embryos
|
1.1 percentage of embryos
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 days after oocyte retrievalPopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Assessed by cleavage stage.
Outcome measures
| Measure |
Menotropin
n=2380 Total number of blastomere
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=4001 Total number of blastomere
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Quality of Embryos
|
7.5 blastomeres
Standard Deviation 2.28
|
7.4 blastomeres
Standard Deviation 2.32
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 days after oocyte retrievalPopulation: The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.
Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).
Outcome measures
| Measure |
Menotropin
n=1338 Embryos reaching blastocyst stage
Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=2075 Embryos reaching blastocyst stage
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
Menotropin, Last Stimulation Day
Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH, Last Stimulation Day
Recombinant FSH at last stimulation day. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity
|
|---|---|---|---|---|
|
Quality of Blastocysts
Excellent quality
|
28.3 percentage of embryos
|
30.7 percentage of embryos
|
—
|
—
|
|
Quality of Blastocysts
Good quality
|
26.5 percentage of embryos
|
22.5 percentage of embryos
|
—
|
—
|
|
Quality of Blastocysts
Neither
|
45.1 percentage of embryos
|
45.8 percentage of embryos
|
—
|
—
|
|
Quality of Blastocysts
Missing
|
0.1 percentage of embryos
|
1.0 percentage of embryos
|
—
|
—
|
Adverse Events
Menotropin
Serious events: 8 serious events
Other events: 179 other events
Deaths: 0 deaths
Recombinant FSH
Serious events: 11 serious events
Other events: 218 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menotropin
n=310 participants at risk
Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 participants at risk
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.65%
2/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.32%
1/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Infections and infestations
Sepsis
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Nervous system disorders
Headache
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
1.9%
6/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
3.2%
10/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.32%
1/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.32%
1/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
0.00%
0/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
Other adverse events
| Measure |
Menotropin
n=310 participants at risk
Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
|
Recombinant FSH
n=309 participants at risk
Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.1%
25/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
11.3%
35/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Gastrointestinal disorders
Nausea
|
11.9%
37/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
12.9%
40/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
21/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
7.8%
24/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
22/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
11.7%
36/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
22.9%
71/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
23.0%
71/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Nervous system disorders
Headache
|
9.4%
29/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
7.1%
22/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
9.7%
30/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
21.4%
66/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.8%
21/310 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
7.1%
22/309 • Adverse events were monitored from the time of obtaining informed consent until the last visit (end of trial).
Adverse events with onset after start of the first investigational medicinal product administration were considered treatment-emergent and are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER